Devices

ABBOTT Clinical Chemistry Calibrator

Model / Serial
Lot Number: 61388M100, 57919M100, 54754M100, and 52632M100.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution including United States, Mexico, Columbia, Uruguay, Puerto Rico, Canada, Hong Kong, New Zealand, Bahamas, Guatemala, Argentina, Germany, Thailand, Trinidad/Tobago, Venezuela, Chile, Brazil, El Salvador, Singapore, Australia, Curacao and Cayman Island.
Product Description
ABBOTT Clinical Chemistry Bilirubin Calibrator, List Number 1E66-04. || The device is intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. The product is used to calibrate assays used to determine bilirubin concentrations in neonate and adult patient samples.
Manufacturer
Abbott Laboratories Inc.
1 Event
- Recall of ABBOTT Clinical Chemistry Calibrator

Manufacturer

Abbott Laboratories Inc.

Manufacturer Address
Abbott Laboratories Inc., 820 Mission St, South Pasadena CA 91030-3142
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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